• Title/Summary/Keyword: Clinical trial center

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Results of Transfer of Cryopreserved Supernumerary Embryos Obtained after Conventional in vitro Fertilization and Intracytoplasmic Sperm Injection (ICSI) (일반적인 체외수정 방법과 세포질내 정자주입술로 얻어진 배아의 동결-융해 후 이식의 결과)

  • Kim, Jeong-Wook;Han, Mi-Hyun;Byun, Hye-Kyung;Jun, Jin-Hyun;Son, Il-Pyo;Koong, Mi-Kyoung;Paik, Eun-Chan;Kang, Inn-Soo;Lee, Ho-Joon
    • Clinical and Experimental Reproductive Medicine
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    • v.24 no.1
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    • pp.111-118
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    • 1997
  • Intracytoplasmic sperm injection (ICSI) recently has been utilized widely as the most successful technique to overcome the unfertilization problem in cases of severe male infertility in couples who could not be treated by conventional IVF. Recently, indications of ICSI have been extended further and more fertilized oocytes become available. Thus, it is necessary to examine the efficiency of freezing the surplus embryos obtained from ICSI. We compared the survival rate and the future outcome of cryopreserved embryos obtained either after conventional IVF or ICSI during the same period. After ICSI or IVF, five best-quality embryos from each patient were transferred in the stimulation cycle and the surplus pronuclear (PN) stage oocytes or multicellular embryos were cryopreserved by slow freezing protocol with 1,2-propanediol (PROH) as a cryoprotectant. A total of 792 embryos from ICSI trial were thawed and 65.2% (516/792) survived. The survival rates of PN stage oocyte, multicellular embryo and PN + multicellular embryo were 63.5%, 68.2%, 64.0%, respectively. After 111 transfers, 34 pregnancies were achieved, corresponding to a clinical pregnancy rate of 30.6% per transfers. We thawed 1033 embryos from IVF trials and 57.5% (594/1033) survived. In IVF cycle, the survival rates of PN stage oocyte, multicellular embryo and PN + multicellular embryo were 58.2%, 65.2%, 40.2%, respectively. Thirty eight clinical pregnancies were established after 134 transfers, corresponding to a pregnancy rate of 28.4% per transfer. The cleavage rate of thawed PN stage oocytes from ICSI trial (61.3%) was significantly higher than those from conventional IVF (53.4%). The developmental rates of good embryo (${\geqq}$ grade II) in thawed PN stage oocytes obtained from conventional IVF and ICSI were 63% and 65%, respectively. We concluded that PN stage oocytes, multicellular embryos resulting from ICSI procedure can be successfully frozen/thawed with reasonable clinical pregnancy rates comparable to those of IVF.

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Physiochemical and Quality Characteristics of Young Radish (Yulmoo) Kimchi Cultivated by Organic Farming (유기농법에 의해 재배된 열무김치의 품질 및 기능적 특성)

  • Jung, Su-Jin;So, Byung-Ok;Shin, Sang-Wook;Noh, Sun-Ok;Jung, Eun-Soo;Chae, Soo-Wan
    • Journal of the Korean Society of Food Science and Nutrition
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    • v.43 no.8
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    • pp.1197-1206
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    • 2014
  • This study compared and analyzed the physiochemical and quality characteristics of young radish kimchi made with YR-FNC or YR-GC cultivated by organic farming as well as kimchi made with young radish cultivated by chemical composting/general farming (YR-Control). YR-Control showed higher contents of water and crude protein than YR-FNC and YR-GC kimchi but lower contents of crude ash, dietary fiber, and vitamin C. YR-FNC and YR-GC kimchi also showed higher contents of P and Cu than YR-Control but lower contents of N, K, Ca, Mg, Fe, and Zn. YR-Control fermentation progressed faster than that of YR-FNC or YR-GC after 24 days, and YR-Control more rapidly reached an appropriate pH. On the other hand, YR-FNC and YR-GC kimchi fermentation progressed slow and did not reach a pH level below 5.3. For period of fermentation, YR-Control and YR-FNC kimchi showed no significant difference in reducing sugar content, whereas that of YR-GC kimchi decreased significantly after 24 days of fermentation (P<0.002). YR-FNC and YR-GC kimchi showed 1.5~3 times higher total polyphenol and flavonoid contents than YR-Control at the beginning of fermentation, whereas YR-Control and YR-FNC kimchi showed a significant increase in total polyphenol and flavonoid contents during the fermentation period. By day 7 of fermentation, YR-FNC kimchi showed higher contents of lactic acid bacteria and total microbes than YR-Control. In the sensory evaluation, YR-FNC and YR-GC kimchi showed higher preference values than YR-Control. Therefore, kimchi made from young radish cultivated by organic farming has a longer freshness period than control kimchi and is characterized by excellent sensory quality, increased physiological contents, and improved beneficial health effects.

Acupuncture for Chronic Fatigue Syndrome and Idiopathic Chronic Fatigue : a Protocol for a Pilot Randomized Controlled Trial (만성피로증후군과 특발성 만성피로에 대한 침 치료의 유효성 및 안전성 평가 : 무작위 대조 예비 임상연구 프로토콜)

  • Kim, Jung-Eun;Kang, Kyung-Won;Kim, Tae-Hun;Jung, So-Yong;Kim, Ae-Ran;Shin, Mi-Suk;Park, Hyo-Ju;Hong, Kwon-Eui;Choi, Sun-Mi
    • Korean Journal of Acupuncture
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    • v.28 no.3
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    • pp.151-163
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    • 2011
  • Objectives : Our aim is to evaluate feasibility for massive clinical research and to make basic analysis of efficacy and safety of acupuncture treatment for chronic fatigue syndrome and idiopathic chronic fatigue. Methods : This study is a protocol for a pilot randomized controlled trial. It was developed through literature searches and discussions among researchers. Results : Forty participants allocated to acupuncture group and wait-list group. Participants allocated to acupuncture group will be treated three times per week for a total of 12 sessions over four weeks. Eight points (GV20; bilatral GB20, BL11, BL13, BL15, BL18, BL20, BL23) have been selected for the acupuncture group. Participants in the wait-list group will not receive acupuncture treatment during study period and follow-up will be made in the 5th and 9th weeks after random allocation. Then the same acupuncture treatment as that performed to the acupuncture group will be made to the wait-list group. Fatigue Severity Scale, a short form of Stress Response Inventory, Beck Depression Inventory, and Insomnia Severity Index will be used as outcome variables to evaluate the efficacy of acupuncture. Safety will be assessed at every visit. Conclusions : The trial based on this study will be performed. The results of the trial will provide basis for the efficacy and safety of acupuncture treatment for chronic fatigue syndrome and idiopathic chronic fatigue.

Systematic Review for the Development of the Clinical Study with Economical Assessment Protocol on Facial palsy (얼굴마비의 임상연구병행 경제성평가 프로토콜 개발을 위한 체계적 문헌고찰연구)

  • Gong, Na-Gyeong;Seo, Eunsung;Seon, Ji-Hye;Kim, Nam-Kwen
    • The Journal of Korean Medicine
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    • v.38 no.1
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    • pp.46-55
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    • 2017
  • Objectives: The aim of this study is reviewing the literature to extract the key parameter, study design, perspective, cost-effectiveness index and find the calibration parameter for the clinical study with economical evaluation protocol on facial palsy. Methods: Literature search is performed using PUBMED for literature published from January 2000 to December 2016. We included randomized controlled trials(RCTs) and modelling study with economic assessment in which human participated. Results: As a result of literature search, the 198 articles were found. After reviewing the title, abstract and full text, the 5 articles were selected. Selected articles are classified into 4 RCT studies dealing with quality of life and 1 CEA(cost-effectiveness analysis) study. Conclusions: We found reliable key parameters, calibration parameters and elements of economical assessment study, which might be necessary factors for developing research protocol of clinical trial with economic evaluation about facial palsy patients.

Effects of Schisandra chinensis fruit extract and gomisin A on the contractility of penile corpus cavernosum smooth muscle: a potential mechanism through the nitric oxide - cyclic guanosine monophosphate pathway

  • Choi, Bo Ram;Kim, Hye Kyung;Park, Jong Kwan
    • Nutrition Research and Practice
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    • v.12 no.4
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    • pp.291-297
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    • 2018
  • BACKGROUND/OBJECTIVES: This study evaluated the effects and molecular mechanisms of the Schisandra chinensis fruit extract (SC) and its major compound gomisin A (GA), on the contractility of rabbit penile corpus cavernosum smooth muscle (PCCSM). MATERIALS/METHODS: PCCSM was exposed to SC or GA after appropriate pretreatment with nitric oxide synthase (NOS) blocker, guanylate cyclase blocker, adenylyl cyclase blocker or protein kinase A blocker. Subsequently, we evaluated the cyclic nucleotide in the perfusate by radioimmunoassay, protein expression level of neuronal NOS (nNOS) and endothelial NOS (eNOS) by western blot, and the interaction of SC or GA with udenafil and rolipram. RESULTS: Both SC and GA induce PCCSM relaxations in a concentration-dependent manner. Pretreatment with NOS blocker, guanylate cyclase blocker, adenylyl cyclase blocker or protein kinase A blocker result in significantly decreased relaxation. SC and GA also induce the levels of cyclic nucleotide in the perfusate in a concentration-dependent manner. Perfusion with GA also showed significantly higher levels of eNOS protein. Furthermore, the udenafil and rolipram induced relaxations of PCCSM were enhanced after exposure to SC and GA. Our results indicate that SC and GA induce the relaxation of PCCSM via the nitric oxide (NO)-cGMP and cAMP signaling pathways. CONCLUSIONS: The SC and GA are potential alternative treatments for men who want to consume natural products to ameliorate erectile function, or who do not respond to the commercially available medicines.

Preliminary Study for Development of Pattern Identification Tool of Chronic Cough (만성기침 변증도구 개발을 위한 기초연구)

  • Kim, Kwan-il;Shin, Seung-won;Lee, Na-la;Lee, Beom-joon;Jung, Hee-jae;Jung, Sung-ki;Lee, Jun-hee
    • The Journal of Internal Korean Medicine
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    • v.36 no.1
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    • pp.22-39
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    • 2015
  • Objectives : The aim of this study was to develop a standard tool of pattern identification for chronic cough, which will be applied to clinical research. Methods : The items and structures of the instrument were based on reviews of textbooks and published literature. The advisor committee on this study consisted of 11 Korean respiratory internal medicine professors, one clinical fellow, and five clinicians with 10 years of experience. The questionnaire, which includes the signs and symptoms of chronic cough, was studied by the delphi method. Delphi examination was carried out via email, through evaluating the importance of symptoms included in each pattern. Results : We divided the pattern identification of chronic cough into five patterns: Wind-Cold, Phlegm-Turbidity, Liver-Fire, Lung Deficiency, and Kidney Yang Deficiency. By the Delphi method and a score evaluation, 38 items were chosen for pattern identification of chronic cough. Conclusions : Through this study, we created a Korean instrument for the pattern identification tool for chronic cough. We expect to apply this tool to subsequent research as its validity and reliability are further confirmed.

Quercetin Relaxed the Smooth Muscle of Rabbit Penile Corpus Cavernosum by Activating the NO-cGMP Signaling Pathway

  • Choi, Bo Ram;Kim, Hye Kyung;Park, Jong Kwan
    • Natural Product Sciences
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    • v.23 no.3
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    • pp.169-174
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    • 2017
  • The aim of this study was to investigate the effect and action mechanism of quercetin on penile corpus cavernosum smooth muscle (PCCSM). PCCSM precontracted with phenylephrine (Phe) was treated with four different concentrations of quercetin ($10^{-7}$, $10^{-6}$, $10^{-5}$ and $10^{-4}M$). PCCSM were preincubated with N-Nitro-L-arginine methyl ester hydrochloride (L-NAME) and 1H-[1,2,4]oxadiazolo[4,3-a]quinoxalin-1-one (ODQ) to block nitric oxide synthase and guanylate cyclase, respectively. The changes in PCCSM tension were recorded, and cyclic nucleotides in the perfusate were measured by radioimmunoassay. The interactions of quercetin with phosphodiesterase type 5 inhibitors (PDE5-Is) such as sildenafil, udenafil and mirodenafil, were also evaluated. PCCSM relaxation induced by quercetin occurred in a concentrationdependent manner. The application of quercetin to PCCSM pre-treated with L-NAME and ODQ significantly inhibited the relaxation. Quercetin significantly increased cGMP in the perfusate. Furthermore, quercetin enhanced PDE5-Is-induced relaxation of PCCSM. Quercetin relaxed the PCCSM by activating the NO-cGMP signaling pathway, and it may be a therapeutic candidate or an alternative treatment for patients with erectile dysfunction who do not completely respond to PDE5-Is.

Effects of adjunctive daily phototherapy on chronic periodontitis: a randomized single-blind controlled trial

  • Jung, Gyu-Un;Kim, Jin-Woo;Kim, Sun-Jong;Pang, Eun-Kyoung
    • Journal of Periodontal and Implant Science
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    • v.44 no.6
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    • pp.280-287
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    • 2014
  • Purpose: The purpose of this randomized single-blind controlled trial was to elucidate the clinical and antimicrobial effects of daily phototherapy (PT) as an adjunct to scaling and root planing (SRP) in patients with chronic periodontitis. Methods: The study was conducted from December 2013 to May 2014 at Ewha Womans University Mokdong Hospital, Seoul, Korea. Forty-one patients with mild to moderate chronic periodontitis were randomly divided into two therapeutic groups in a 1:1 ratio: SRP+PT and SRP (control) groups. All participants underwent full-mouth SRP. PT was performed thrice a day for a month by using electric toothbrushes with embedded light-emitting diodes. Plaque index, gingival index, probing pocket depth (PPD), clinical attachment level (CAL), and bleeding on probing were assessed before (baseline) and four weeks after (follow-up) the treatment. Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola, Prevotella intermedia, Fusobacterium nucleatum, Parvimonas micra, Campylobacter rectus, Eikenella corrodens, Streptococcus mutans, and Streptococcus sobrinus levels were detected by a real-time polymerase chain reaction at the same points in time. Results: The clinical parameters improved in both the groups. At the follow-up assessment, PPD was significantly decreased in the SRP+PT group (P=0.00). Further, PPD and CAL showed significantly greater changes in the SRP+PT group than in the SRP group (PPD, P=0.03; CAL, P=0.04). P. gingivalis and T. forsythia levels decreased in this group, but no significant intergroup differences were noted. Conclusions: Adjunctive PT seems to have clinical benefits, but evidence of its antimicrobial effects is not sufficient. Long-term studies are necessary to develop the most effective PT protocol and compare the effectiveness of PT with and without exogenous photosensitizers.

Necessity of pharyngeal anesthesia during transoral gastrointestinal endoscopy: a randomized clinical trial

  • Tomoyuki Hayashi;Yoshiro Asahina;Yasuhito Takeda;Masaki Miyazawa;Hajime Takatori;Hidenori Kido;Jun Seishima;Noriho Iida;Kazuya Kitamura;Takeshi Terashima;Sakae Miyagi;Tadashi Toyama;Eishiro Mizukoshi;Taro Yamashita
    • Clinical Endoscopy
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    • v.56 no.5
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    • pp.594-603
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    • 2023
  • Background/Aims: The necessity for pharyngeal anesthesia during upper gastrointestinal endoscopy is controversial. This study aimed to compare the observation ability with and without pharyngeal anesthesia under midazolam sedation. Methods: This prospective, single-blinded, randomized study included 500 patients who underwent transoral upper gastrointestinal endoscopy under intravenous midazolam sedation. Patients were randomly allocated to pharyngeal anesthesia: PA+ or PA- groups (250 patients/group). The endoscopists obtained 10 images of the oropharynx and hypopharynx. The primary outcome was the non-inferiority of the PA- group in terms of the pharyngeal observation success rate. Results: The pharyngeal observation success rates in the pharyngeal anesthesia with and without (PA+ and PA-) groups were 84.0% and 72.0%, respectively. The PA- group was inferior (p=0.707, non-inferiority) to the PA+ group in terms of observable parts (8.33 vs. 8.86, p=0.006), time (67.2 vs. 58.2 seconds, p=0.001), and pain (1.21±2.37 vs. 0.68±1.78, p=0.004, 0-10 point visual analog scale). Suitable quality images of the posterior wall of the oropharynx, vocal fold, and pyriform sinus were inferior in the PA- group. Subgroup analysis showed a higher sedation level (Ramsay score ≥5) with almost no differences in the pharyngeal observation success rate between the groups. Conclusions: Non-pharyngeal anesthesia showed no non-inferiority in pharyngeal observation ability. Pharyngeal anesthesia may improve pharyngeal observation ability in the hypopharynx and reduce pain. However, deeper anesthesia may reduce this difference.

A Qualitative Study on Management Behaviors about Blood Pressure of Participants in Moxibustion Clinical Trial for Hypertension (고혈압-뜸 임상시험 참여자들의 혈압 관리행동에 대한 질적연구)

  • Moon, A-Ji;Kim, Tae-Jung;Lee, Seoung-Geun;Kim, Nam-Kwen;Lee, Key-Sang
    • The Journal of Internal Korean Medicine
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    • v.33 no.4
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    • pp.543-557
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    • 2012
  • Objectives : The purpose of this study which adopted a qualitative method was to evaluate blood pressure management behaviors of pre- and stage 1 hypertension patients and to provide fundamental data for developing a strategy about proper oriental medical treatment through analyzing factors related to a moxibustion clinical trial. Methods : Semi-structured interviews that focused on personal experiences with hypertension and its management were conducted with 10 hypertensive patients. The interviews lasted for approximately 50 minutes. Results : Most participants recognized that the direct cause of high blood pressure was unhealthy behavior rather than inheritance. Thus, the hypertensive patient believed they could recover their blood pressure to a normal level through removing the direct cause of hypertension instead of taking drugs. The reasons for these statements were that the drugs for controlling hypertension are not natural and they may have side effects. On future management plan of patients, most of them will continue to keep moxibustion and healthy behavior in the well-controlled blood pressure group. However in the uncontrolled blood pressure group, there was an increasing tendency to begin medication. Conclusions : For developing a strategy for an individual approach to hypertension management, we need to develop a client-centered attitude and strategy. That is, we need to tailor our approach to individual cases to avoid generalizations and stereotyping when developing an adherence increasing strategy.